Anal IncontinenceNCT03252951
Physical Therapy for Anal Incontinence
A study testing Eccentric Training, Concentric Training and Isometric Training in people with Anal Incontinence and Fecal Incontinence, run by San Diego State University at 1 site in United States.
Trial summary
Anal incontinence is a significant public health problem estimated to affect 7-15% of women in the United States. Traditional rehabilitation strategies include biofeedback and Kegel exercises for pelvic floor muscle strengthening, but this strategy does not incorporate strategies for resistance training that are known… Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Anal Incontinence, Fecal Incontinence
- What is being tested?
- Eccentric Training, Concentric Training and Isometric Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AI based on FISI questionnaire
- FISI scores between 10 and 45
- able to voluntarily contract pelvic floor muscles based on manometry measures
Who cannot join
- FISI score below 10 (mild disease) or greater than 45 (severe disease)
- manometry measure below the 10th percentile of normal (lack of muscle) or above 70th percentile of normal (little room to improve strength)
- history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing inflammatory bowel disease
- constipation that is directly linked to neurological conditions such as spinal and peripheral nerve pathologies
- large pelvic organ prolapse (greater than stage 3)
- inability to contract the pelvic floor muscles on command
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92102
About this study
Official title: An Innovative Rehabilitation Approach for Women With Anal Incontinence
Anal incontinence is a significant public health problem estimated to affect 7-15% of women in the United States. Traditional rehabilitation strategies include biofeedback and Kegel exercises for pelvic floor muscle strengthening, but this strategy does not incorporate strategies for resistance training that are known to cause muscle strengthening and hypertrophy in other muscles in the body. This study aims to investigate whether a novel pelvic floor resistance exercise program will increase pelvic floor muscle strength and improve anal incontinence and has the potential to impact rehabilitation strategies for the millions of women affected anal incontinence.
Read the detailed description
The current proposal is focused on examining whether a novel resistance exercise program for the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal incontinence. Anal incontinence is a significant public health issue that is estimated to impact 7-15% of women. Traditional rehabilitation strategies such as Kegel exercises and biofeedback are a noninvasive strategy designed to strengthen the pelvic floor muscles, however, these exercises are performed with no resistance. There is a large body of evidence indicating that for muscle strengthening and hypertrophy to occur, exercises must be performed against resistance. Therefore, we have designed a novel exercise program for the pelvic floor that incorporates principals of resistance training known to be effective in other muscles in the body. The long-term goal of this research is to determine the most appropriate noninvasive strategies and interventions to improve pelvic floor function and symptoms of anal incontinence. This project is the first step in achieving this goal. The overall purpose of the current proposal is to determine whether novel physical therapy interventions are more effective than traditional biofeedback strategies in the treatment of anal incontinence. The specific aims of the proposal are: (1) To describe the use of the Functional Lumen Imaging Probe (FLIP) for pelvic floor exercise; (2) To determine whether eccentric, concentric, or isometric exercise training of the pelvic floor has a positive impact on the pelvic floor muscles and on symptoms of anal incontinence compared to traditional biofeedback training; (3) To determine whether using the FLIP in the vagina is as effective as its use in the anal canal for treatment of anal incontinence. To test these aims, the approach includes a randomized controlled exercise trial with use of validated measures of muscle function, muscle hypertrophy and validated symptom measures. This proposal describes an innovative approach to rehabilitation of the pelvic floor muscles that will provide information about pelvic floor function and that has the potential to shift the treatment paradigm for women with pelvic floor disorders.
- Conditions
- Anal Incontinence, Fecal Incontinence
- Being tested
- Eccentric Training, Concentric Training, Isometric Training, Biofeedback
- Medical subject headings
- Encopresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric TrainingBehavioural
Different Anal Sphincter Exercise Types for muscle hypertrophy
Concentric TrainingBehavioural
Different Anal Sphincter Exercise Types for muscle hypertrophy
Isometric TrainingBehavioural
Different Anal Sphincter Exercise Types for muscle hypertrophy
BiofeedbackBehavioural
Standard of Care Biofeedback Training
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Training | Experimental | Not described Receives: Behavioral: Eccentric Training |
| Concentric Training | Experimental | Not described Receives: Behavioral: Concentric Training |
| Isometric Training | Experimental | Not described Receives: Behavioral: Isometric Training |
| Biofeedback | Active comparator | Not described Receives: Behavioral: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Length Tension Manometry after 12 weeks
change from baseline to 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
change from baseline to 12 weeks
Measured: 12 weeks
Change in FISI score after 12 weeks
change from baseline to 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Lori Tuttle, San Diego State University
- Investigators
- Lori Tuttle, PT, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252951
- Sponsor's protocol ID
- 141728
- Status last verified
- Oct 2022
- First submitted
- 14 Aug 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Rehabilitation Approach for Women With Anal Incontinence
- ClinicalTrials.gov ID
- NCT03252951
- Acronym / sponsor ID
- 141728
- Conditions
- Anal Incontinence, Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anal incontinence is a significant public health problem estimated to affect 7-15% of women in the United States. Traditional rehabilitation strategies include biofeedback and Kegel exercises for pelvic floor muscle strengthening, but this strategy does not incorporate strategies for resistance training that are known to cause muscle strengthening and hypertrophy in other muscles in the body. This study aims to investigate whether a novel pelvic floor resistance exercise program will increase pelvic floor muscle strength and improve anal incontinence and has the potential to impact rehabilitation strategies for the millions of women affected anal incontinence.
Detailed description
The current proposal is focused on examining whether a novel resistance exercise program for the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal incontinence. Anal incontinence is a significant public health issue that is estimated to impact 7-15% of women. Traditional rehabilitation strategies such as Kegel exercises and biofeedback are a noninvasive strategy designed to strengthen the pelvic floor muscles, however, these exercises are performed with no resistance. There is a large body of evidence indicating that for muscle strengthening and hypertrophy to occur, exercises must be performed against resistance. Therefore, we have designed a novel exercise program for the pelvic floor that incorporates principals of resistance training known to be effective in other muscles in the body. The long-term goal of this research is to determine the most appropriate noninvasive strategies and interventions to improve pelvic floor function and symptoms of anal incontinence. This project is the first step in achieving this goal. The overall purpose of the current proposal is to determine whether novel physical therapy interventions are more effective than traditional biofeedback strategies in the treatment of anal incontinence. The specific aims of the proposal are: (1) To describe the use of the Functional Lumen Imaging Probe (FLIP) for pelvic floor exercise; (2) To determine whether eccentric, concentric, or isometric exercise training of the pelvic floor has a positive impact on the pelvic floor muscles and on symptoms of anal incontinence compared to traditional biofeedback training; (3) To determine whether using the FLIP in the vagina is as effective as its use in the anal canal for treatment of anal incontinence. To test these aims, the approach includes a randomized controlled exercise trial with use of validated measures of muscle function, muscle hypertrophy and validated symptom measures. This proposal describes an innovative approach to rehabilitation of the pelvic floor muscles that will provide information about pelvic floor function and that has the potential to shift the treatment paradigm for women with pelvic floor disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eccentric Training | Experimental | Behavioral: Eccentric Training |
| Concentric Training | Experimental | Behavioral: Concentric Training |
| Isometric Training | Experimental | Behavioral: Isometric Training |
| Biofeedback | Active comparator | Behavioral: Biofeedback |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AI based on FISI questionnaire
- FISI scores between 10 and 45
- able to voluntarily contract pelvic floor muscles based on manometry measures
Key exclusion criteria (7 listed)
- FISI score below 10 (mild disease) or greater than 45 (severe disease)
- manometry measure below the 10th percentile of normal (lack of muscle) or above 70th percentile of normal (little room to improve strength)
- history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing inflammatory bowel disease
- constipation that is directly linked to neurological conditions such as spinal and peripheral nerve pathologies
- large pelvic organ prolapse (greater than stage 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric TrainingDifferent Anal Sphincter Exercise Types for muscle hypertrophy | Behavioural | Eccentric Training |
| Concentric TrainingDifferent Anal Sphincter Exercise Types for muscle hypertrophy | Behavioural | Concentric Training |
| Isometric TrainingDifferent Anal Sphincter Exercise Types for muscle hypertrophy | Behavioural | Isometric Training |
| BiofeedbackStandard of Care Biofeedback Training | Behavioural | Biofeedback |
Primary outcome
Change in Length Tension Manometry after 12 weeks
Time frame: 12 weeks
change from baseline to 12 weeks
2 secondary outcomes
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
Time frame: 12 weeks
Change in FISI score after 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Anal Incontinence
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Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
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Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Tuttle, PT, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Training, Concentric Training and Isometric Training in people with Anal Incontinence and Fecal Incontinence, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Length Tension Manometry after 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.